Director, Analytical Operations

Job Description

Specific Responsibilities:

• Lead, coach, develop, and inspire a team of seven analysts and scientists
• Coordinate and execute phase appropriate Critical Quality Attribute assessment studies
• Collaborate with research for the selection of clinical candidate and developability studies
• Collaborate with analytical and process development function for the execution of relevant studies necessary to support process development, process characterization and validation.
• Plan and execute analytical characterization studies to support phase appropriate comparability studies and reference standard qualification
• Write and review relevant sections of regulatory filings, and reports used as source documents
• Perform critical data review, design the relevant studies and provide directions for troubleshooting and investigation.
• Guide the execution of relevant forced degradation and isolation and characterization of product and process related impurities
• Proactively engage in collaboration with internal and external stakeholders to incorporate good practice and industrial trend into analytical development and control strategies.
• Explore, develop, acquire new technologies 
• Serve as an analytical representative on pharmaceutical development project teams and provides comprehensive project analysis to senior management.
• Partake in BAO leadership and work closely with the cross functional groups to achieve project and team strategic goals.

Essential Education, Experiences and Skills:

• Ph.D. in Biological Sciences, Chemistry, Chemical engineering, Pharmaceutical Sciences, or relevant field with ≥ 15 years of industry experience.
• Must have a proven track record in mass spectrometry, proteomics, and protein biochemistry
• Broad and direct experience of managing a variety of analytical activities including characterization method development, reference standard, product characterization, comparability and CQA assessments.
• Must have experience in authoring analytical sections of early and late stage regulatory filings
• Must have a robust understanding of analytical operations and regulatory expectations
• Be an effective communicator of ideas, project goals and results to team members across cross-functional roles/departments.
• Be self-motivated and organized, ability to prioritize multiple projects and excellent problem-solving skills.
• Must think critically and creatively.
• Excellent communication skills (both verbal and technical) and strong interpersonal skills are required.
• Innovative, proactive, and resourceful; committed to excellence, quality and continuous improvement.

Preferred Skills:

• Track record of publications in peer reviewed journals and oral communications at relevant conferences a plus
• Experience in several of the following fields is strongly desired: Analytical chemistry, biochemistry, biological Mass Spectrometry, high performance or ultra-performance liquid chromatography, electrophoretic separations, chemical and biophysical structural elucidation, and bioinformatics.